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TGA Action ID	RC-2026-RN-00782-1
Type of Product	Medical Device
Product Name/Description	LULA Nicotine Salt Pods - Unflavoured 50 mg/mL Batch: 20250930 Expiry: 30 September 2027 Supplied via SAS pathway
ARTG Number
Action Type	Recall
Action Level	Retail
Hazard Classification	Class II
Reason for the Action	TGA testing has identified a potential non-compliance for this product. Formaldehyde at a concentration of 0.0278 mg/mL in a sample was detected, which exceeds the maximum permitted concentration of 0.022 mg/mL specified under TGO 110. Formaldehyde may cause eye and respiratory irritation, with risk dependent on the level and duration of exposure. Formaldehyde also has recognised hazards associated with repeated or long-term inhalation exposure, including chronic effects on respiratory tissues and carcinogenicity. However, formaldehyde at the level detected in this sample would not reasonably be expected to result in serious acute toxicity during normal use. No adverse events associated with the affected batch have been reported to date. This action was undertaken prior to TGA notification.
Instructions for Customers/Users	Customers are to: · Cease supply of the affected batch; · Identify and segregate any remaining affected stock held within the pharmacy; · Clearly mark or otherwise identify it as being quarantined; · Return affected stock currently on hand. A full credit will be provided for all affected stock.
Action Commencement Date	9/10/2026
Responsible Entity	Bay Pharma Pty Ltd
Contact Information	1300 938 651 - BayPharma